Distress in patients with cancer influences their quality of life. Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended. However, the effects of the use of the DT on the psychosocial wellbeing of the patient are unknown.
Trang 1S T U D Y P R O T O C O L Open Access
The effectiveness of a nurse-led
intervention with the distress thermometer
for patients treated with curative intent for
breast cancer: design of a randomized
controlled trial
Floortje K Ploos van Amstel1*, Judith B Prins2, Winette T A van der Graaf1,3, Marlies E W J Peters1
and Petronella B Ottevanger1
Abstract
Background: Distress in patients with cancer influences their quality of life Worldwide, screening on distress with the Distress Thermometer (DT) in patients with cancer is recommended However, the effects of the use of the DT
on the psychosocial wellbeing of the patient are unknown A study to assess the psychosocial consequences of the systematic use of the DT and its discussion by a nurse as compared to the usual care provided to outpatients who are treated for primary breast cancer is needed
Methods/design: The effectiveness of a nurse-led intervention with the DT will be tested in a non-blinded randomized controlled trial Patients treated with curative intent for breast cancer will be recruited from the Radboud University Medical Center The intervention consists of the DT together with discussion of the results with the patient by a trained oncology nurse added to the usual care Patients will be randomly allocated (1:1)
to either receive usual care or the usual care plus the intervention Primary outcome measure is global quality
of life measured with the EORTC QLQ-C30 The functional and symptom scales of the EORTC QLQ-C30 and BR23, Hospital Anxiety and Depression Scale, Impact of Event Scale, Illness Cognition Questionnaire and DT (baseline and final measurement only) will be used to measure secondary outcomes Questionnaires are obtained in both arms at baseline, after completion of each type of cancer treatment modality and during follow up, with a three and six months’ interval during the first and second year respectively
Discussion: This study will be the first randomized controlled longitudinal study about the effectiveness of the
DT as nurse led-intervention In case of proven effectiveness, future implementation and standardization of use
of the DT as part of routine care will be recommended
Trial registration: This study is registered at clinicaltrial.gov march 17, 2010 (NCT01091584)
Keywords: Distress, Distress thermometer, Breast cancer, Quality of life, RCT, Nurse-led intervention, Nurse,
Oncology nurse, Screening, Psychosocial care
* Correspondence: floor.ploosvanamstel@radboudumc.nl
1 Department of Medical Oncology, Radboud University Medical Center, P.O.
Box 91016500 Nijmegen, The Netherlands
Full list of author information is available at the end of the article
© 2016 The Author(s) Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made The Creative Commons Public Domain Dedication waiver
Trang 2With an incidence of more than 1.67 million women
yearly, breast cancer is the second most frequently
oc-curring type of all cancers in the world [1] Despite the
reported increase in survival rate, the diagnosis breast
cancer has a serious impact on a woman’s life [2, 3]
The National Comprehensive Cancer Network (NCCN)
summarizes the problems that patients with cancer
may encounter with the word“distress” and defines it as
‘a multifactorial unpleasant emotional experience of a
psychological (cognitive, behavioral, emotional), social
and/or spiritual nature that may interfere with the
abil-ity to cope effectively with cancer, its physical symptoms
and its treatment Distress extends along a continuum
ranging from common normal feelings of vulnerability,
sadness and fears to problems that can become
disab-ling such as depression, anxiety, panic, social isolation
and existential and spiritual crisis’[4] When patients
experience distress it impinges on their quality of life
and the time for recovery during and after treatment
[5–10] The current NCCN guideline describes that
20-47 % of patients with newly diagnosed and recurrent
cancer experience a significant level of distress [4]
Offering basic psychosocial care is a core task for
physi-cians and nurses Psychosocial care could consist of
edu-cation about the disease and treatment process, emotional
support, as well as support in choosing treatment
mo-dalities For optimal support, it is important to screen
for levels of distress and the unmet needs of the patient
[11, 12]
Screening for distress
The Distress Thermometer (DT) has become a worldwide
standard screening tool for distress in cancer patients
[4, 9, 10, 13–20] that facilitates a systematic approach
to distress detection It consists of a VAS score and a
problem list Without a systematic distress assessment
patients are at risk of under diagnosis and treatment
[4] Its use can assist in the timely detection of distress
and facilitate early intervention A screening instrument
like the DT provides guidance for discussions with
pa-tients Its use gives attention and focus to psychosocial
issues, an increased awareness of distress and more
effect-ive communication between healthcare professionals and
patients [4]
Recently, an increasing number of papers have been
published on the validity of the DT in different languages
and on different cut-off points [4, 14–18, 21] Additionally,
the DT is used in studies to measure distress related to
various tumor types [19, 20] and at different time points
during treatment and follow-up [9, 10, 22, 23] Studies
about the effectiveness of the utilization of the DT are
scarce Based on current knowledge, only one study
described a non-blinded randomized controlled trial about
the DT in comparison to standard care [24] In this study the DT was assessed once at baseline and patients filled out questionnaires at 1, 6 and 12 months of follow up No effect on costs and no significant improvement on the mood states among patients were found [24] Due to this lack of evidence on effectiveness there is an ongoing discussion about the use of the DT [25–27]
Internationally, it is recommended to implement guidelines to address psychosocial care, with for example the DT, to manage the psychosocial impact of cancer as part of daily oncology care [4, 28, 29]
However, it is still unconfirmed that systematic screening with the DT and a subsequent discussion of the results will lead to improved patients’ quality of life
It is striking that the use of the DT is implemented as standard care worldwide without any evidence of effect-iveness We therefore decided to investigate the added value of using the DT systematic to improve their quality
of life by a nurse in oncology care in a randomized con-trolled trial, in patients diagnosed with breast cancer The decision to focus on patients with breast cancer was made for the following reasons; (1) breast cancer has a high incidence, (2) most patients undergo a long treatment process and (3) patients have high survival rates The high survival rate is essential to be able to measure the effects of the intervention in preventing long-term psychosocial problems
Objective
The primary objective of this randomized controlled trial
is to evaluate the effect of a nurse-led DT intervention on improving the quality of life of patients with breast cancer who are treated with curative intent, compared to usual care, after approximately two years of follow-up
Methods This study will be reported in accordance with the SPIRIT guidelines [30]
Study design The design of the study (also called Nurse Intervention Project) is a non-blinded randomized controlled trial (Fig 1) In the intervention group, a thorough assess-ment using the DT and a discussion of the results by a trained oncology nurse will be added to the usual care Actions based on the outcomes of the DT will be taken
as necessary The control group will receive the usual care without using the DT By comparing the results of the intervention group with the control group the effect
of the intervention can be determined
Participants eligibility
Inclusion criteria: women with histology proven malignancy
of the breast; who will receive treatment with curative
Trang 3intent, written and oral fluency in the Dutch language and
aged≥ 18 years
Exclusion criteria: men, women who have been treated
previously for a malignancy (except adequately treated
cervix carcinoma in situ and basal cell carcinoma of the
skin); women with psychiatric problems that impair
adherence to this study
Recruitment
Patients will be recruited from the population of newly
di-agnosed breast cancer patients at the Radboud University
Medical Center Women who have been diagnosed with
breast cancer and meet the inclusion criteria, will be
asked to participate in this study The patients will be
monitored after surgery, during adjuvant treatment and
approximately two years during the follow up
Immedi-ately following diagnosis participants will be verbally
briefed by a clinical nurse specialist about the study
and given an information pack containing a detailed in-formation sheet and letter of invite to participate in the study This timing is crucial as it is preferable to collect baseline measurement before start of the first treatment modality Following receipt of the information package the patient has several days to consider participation in the study If the patient gives consent for further discus-sion about the study, the investigator will then be in con-tact with the patient by telephone or during the next hospital visit to discuss further potential participation In the time frame between the diagnosis and the start of treatment, the patient usually visits the responsible health-care professional (surgeon, clinical nurse specialist or oncologist) On that day, if appropriate, the patient will be asked to confirm her participation and baseline measure-ments will be taken in the hospital or at home There are paper-and-pencil and electronic versions of the assess-ment available Electronic completion reduces the risk of
Baseline (T0)
No Hormonal Therapy
Stratification
Hormonal Therapy
Final measure (T9)
T R E A T M E N T
2 yr
F O L L O W
U P
T4: Q + DT
Randomization
T6: Q
T7: Q
T1 + T2 +T3:
Q after each treatment
T1 + T2 +T3:
Q +DT after each treatment
Control Intervention
T5: Q T5: Q + DT
T4: Q
T6: Q + DT
T7: Q + DT
T4: Q + DT
Randomization
T6: Q
T7: Q
T1 + T2 +T3:
Q after each treatment
T1 + T2 +T3:
Q +DT after each treatment
Control Intervention
T5: Q T5: Q + DT
T4: Q
T6: Q + DT
T7: Q + DT
Fig 1 Flow-chart of the nurse intervention project Q: Questionnaires, DT: Distress Thermometer Intervention includes a thorough assessment using the DT and a discussion of the results by a trained oncology nurse The questionnaires are: EORTC QLQ-C30 = European Organization for Re-search and Treatment of Cancer, Quality of Life Questionnaire; QLQ-BR23 = Quality of life- Breast Cancer; HADS = Hospital Anxiety and Depression Scale; IES = Impact of Event Scale; ICQ = Illness Cognition Questionnaire; EQ-6D = EuroQol-6D and a diary
Trang 4missing data because the patient has to answer each
ques-tions before sending A paper-and-pencil version of the
questionnaires will be available for those who are not
capable of filling it out electronically
Randomization
The expectation is that approximately 75 % of the
pa-tients will receive hormonal therapy Since mood
swings and fatigue are known side effects of hormonal
therapy [31], we will stratify for hormonal treatment
We therefore will use a randomized block design,
pre-pared by an independent statistician The patients will
be randomized in a 1:1 ratio, immediately after
assess-ment of the adjuvant treatassess-ment plan, which includes
the use of adjuvant hormonal therapy Random
assign-ment using sequentially numbering will be done by a
physician not involved in the study The result of the
randomization will be communicated by e-mail or mail
to the patient by the investigator
Intervention
The intervention comprises of support by the trained
oncology nurse based on the discussion of the DT in
accordance to the protocol for assessing the need for
psychosocial care for cancer patients [13] The
inter-vention is combined with the (follow up) visit to the
outpatient clinic
The DT consists of a thermometer ranging from 0
(no distress) to 10 (extreme distress) In addition the
tool contains 47 questions (yes / no answers) related to
different issues The issues have been categorized into:
practical issues, family / social issues, emotional issues,
religious / spiritual issues, physical issues The DT
con-cludes with the question: “Would you like to talk with a
professional about your problems?” (yes/no/maybe) The
cut-off point is 5 [14]
The following steps will be made for each screening
moment with the DT:
1 The patient will receive an e-mail or mail about the
appointment with the trained oncology nurse, which
will take place in combination with regular visits in
the outpatient clinic
2 The patient will fill out out the DT in the outpatient
clinic a few minutes before the appointment
3 The trained oncology nurse will discuss the DT with
the patient before or after the visit with the
attending healthcare professional The nurse will ask
on which problems the DT score is based and the
mentioned problems on the problem list will be
discussed If the patient reports a lot of problems,
the nurse will ask the patient to prioritize the
problems indicated At the end, the nurse will ask if
the patient would like to be referred to a professional
4 Time allocated to these meetings will last between 5 – 30 min, depending on the severity of the distress and the nature of the problems
5 If the patient reports a DT score of <5 the trained oncology nurse will inquire whether the patient is sufficiently in control of her situation The low distress score and the issues marked on the problem list are discussed briefly At a score≥ 5 on the DT, an extensive exploratory conversation between the nurse and the patient will take place The outcome of this conversation will be discussed in a psychosocial Multi Disciplinary Team (MDT) The MDT has been established to discuss all patients of the intervention group with a score of≥ 5 on the DT and to discuss patients who personally request additional support The participants of the MDT are the attending healthcare professional and/or oncologist, the trained oncology nurse, a social worker and clinical psychologists During the MDT a treatment plan is composed when needed The nurse will propose this plan to the patient by phone
Three oncology nurses will be trained by a clinical psychologist to perform the intervention over three ses-sions A specific manual will be developed during the training sessions and the intervention In order to apply consistency in the content and the discussion of the DT with the patients, those three nurses will receive the same training They should be qualified as a nurse and
be knowledgeable in the course and treatment of breast cancer For financial reasons an independent trained study nurse cannot be hired for this study Because oncology nurses from the wards have a high risk of con-tamination the intervention group while being in contact with patients from both the intervention and the control group, they are not suited to deliver the intervention themselves Therefore, we will select three oncology nurses who are not bedside nurses and are involved in other than breast cancer patient groups on the out-patient clinic In order to build a trustworthy relation-ship and give continuity to the care whenever possibly the patient will meet the same oncology nurse at every visit During this study the DT is not implemented in daily care so the oncology nurses of the departments involved in the study will not use it in daily practice
A short standard report (as incorporated in the manual) will be filled out after each conversation To prevent contamination with other professionals, the report of the conversation will not be included in the medical record of the patient The investigator of the study is also one of the trained oncology nurses who will deliver the interventions
In order to minimize the influence of the investigator on
Trang 5the results of the study, an independent database will be
created and an independent statistician will analyze the
data
Usual care
As already mentioned, the DT will not be implemented in
daily care for patients with breast cancer during this study
period, therefore no professionals taking care of breast
cancer patients will use the DT The usual care consists of
routine follow-up visits with the attending healthcare
pro-fessional (physician or clinical nurse specialist) according
to the Dutch breast cancer guideline [32] (see also
meas-uring time-points) Depending on the judgment of the
re-sponsible health care professional, the patients may be
referred to other health care professionals, if indicated No
psychosocial MDT is available in usual care
Measuring time-points
The baseline measurement will take place preferably
before breast surgery or start of the neo-adjuvant
chemo-therapy During the first year of treatment the assessments
will take place at the end of each treatment modality In
the second and third year, the follow-up visits will be in
line with the recommendations of the Dutch Breast
Cancer guideline [32] This means that data will be
col-lected approximately every 3 months during the first and
every 6 months in the second year after the completion of
adjuvant treatment (except for trastuzumab or hormonal
therapy) This will result in a total of 8 – 10
measure-ments, depending on the number of adjuvant therapies
(see Fig 1) In order to monitor the effects of treatment
on the patients’ well-being in both the short- and
long-term, patients will be followed for two years after
comple-tion of the primary (adjuvant) treatment
At all measuring time-points both groups will receive
questionnaires The DT is included for both groups at
baseline and at the end of the study At those time-points
the results will not be discussed with the patients
Approximately two days before the regular visit to the
at-tending healthcare professional, the patient will be asked
to fill out the questionnaire electronically (Radquest
soft-ware, department of Medical Psychology) or on paper in
the hospital or at home It takes 10–30 min to fill out the
questionnaires Additionally, a diary will be provided to
the patient in which the consumed care and work absence
has to be noted and recorded At the moment the patient
hands in the diary, a new one is provided by mail or
per-sonally In case of non-response, a reminder will be send
within 2 weeks by e-mail or mail
Study outcome measures
Demographic data and the use of psychosocial care are
measured with general questionnaires Medical
disease-specificdata will be collected from the electronic medical
record A checklist will be used to collect the relevant medical records from the patient’s status
Primary outcome measure
The primary outcome will be the global quality of life subscale as defined by the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire- C30 (EORTC QLQ C-30) [33] The items
of the global health and global quality of life scale use a 7-point linear analogue scale (very poor to excellent) [34]
Secondary outcomes
The secondary outcomes will be: breast cancer related quality of life, anxiety, depression, emotional distress, coping, illness cognitions and distress (Table 1)
Functional and symptom scales of the EORTC QLQ C30 will be used to assess the other dimensions of quality of life (see Table 1) Higher scores on the global and function scales implies good quality of life On the symptom scales, low scores indicates less intense symp-toms hence higher quality of life [33-35]
Breast cancer related quality of life will be assessed with the breast cancer related questionnaire EORTC-BR23 which consists of 23 questions and complements the C30 [36]
Anxiety, depression and emotional distress will be measured with the Hospital Anxiety and Depression Scale (HADS) The HADS has two subscales (anxiety and depression) and a total score of emotional distress The questionnaire consists of 14 questions with scores ranging from 0 (not at all) to 3 (very much) [37–39] The presence of coping problems will be measured with Impact of Event Scale (IES) This questionnaire provides an inventory of the effects of a shocking event and focuses on the person’s feelings and thoughts over the previous seven days The IES has two subscales: in-trusion and avoidance The scores range from‘not at all’,
‘rarely’, ‘sometimes’ and ‘often’[40]
To identify the role of illness cognitions in relation to the treatment effectiveness we will use the Illness Cogni-tion QuesCogni-tionnaire (ICQ) There are three subscales: helplessness, acceptance and perceived benefits The scores range from 1 (none) to 4 (entirely) [41]
Distresswill also be measured with the DT at baseline and final measurement for both groups (see Fig 1) [14]
In case we will find differences between both groups
on quality of life we will further explore the health care utilization These data will be gathered with a diary that the patients will take home between measurement time-points Patients will register their health care utilization, cancer-related absence from work, specific medication and care Quality of Life in relation to economic evalua-tions will be measured using the EuroQol-6D (EQ-6D) The EQ-6D comprises both the EQ-5D and an additional
Trang 6dimension namely, cognition The EQ-5D measures
health on five dimensions (mobility, self-care, usual
activities, pain/discomfort, anxiety/depression) Every
dimension is differentiated in three levels: no problems,
some problems, and extreme problems The EuroQol
Visual Analogue Scale (EQ-VAS) will also be used The
EQ-VAS provides a subjective assessment of quality of
life on a scale ranging from 0 (worst health) to 100
(best health) [42]
Evaluation
At the end of the study, patients will be asked to evaluate
their experiences during the study period In addition, the
intervention group will be asked to evaluate their experi-ence of the intervention The control group will be asked about their need for more psychosocial support during treatment or follow up
Data management
We expect most patients will fill out the questionnaires electronically The results of the questionnaires will be converted to SPSS by a data manager Only the investi-gators have access to the coding, storage of all ques-tionnaires and the final dataset The paper and pencil questionnaires and medical characteristics will be en-tered in the SPSS database by a research assistant For
Table 1 Measurements and time points of the nurse intervention project
EORTC QLQ-C30 Functional scales: physical, role, emotional, social, and
cognitive functioning (15 items)
Range 15 –60 Symptom scales: fatigue, pain, nausea/vomiting (7 items) X X X Range 7 –28
Global Health and global quality of life* (2 items) X X X 7 point linear analogue scale
Range 2 –14
sexual enjoyment, future perspective (8 items)
Range 8 –32 Symptoms scales: arm symptoms, breast symptoms,
systemic therapy side effects, upset by hair loss (15 items)
Scale: range 0 –10
Subscales:
Anxiety (7 items) Depression (7 items)
Range 0 –42 (total scale) Range 0 –21
Range 0-21
Subscales:
Intrusion (7 items) Avoidance (8 items)
Range 0 –75 (total score) Range 0 –35
Range 0-40
Subscales:
Helplessness (6 items) Acceptance (6 items) Perceived benefits (6 items)
Range 6 –24 Range 6 –24 Range 6-24
Scale: range 0 –100 Dimensions: mobility, self-care, usual activities, pain/discomfort,
anxiety/depression and cognition (6 items)
X X X Range 1 –3 for each dimension.
*primary outcome
1
only in the intervention group
Abbreviations: T0 baseline measurement, T1-T3 measurement after each treatment and T4-T8 follow up, T9 final measure, EORTC QLQ-C30 European organization for research and treatment of cancer, quality of life questionnaire, QLQ-BR23 quality of life- breast cancer, DT distress thermometer, HADS hospital anxiety and depression scale, IES impact of event scale, ICQ illness cognition questionnaire, EQ-6D euroQol-6D
Trang 7the validity of these data, for 10 % of the data double
entry of data will be done A statistician will check data
value ranges All source data will be stored for 15 years
Power calculations
Based on prior clinical studies [34] a difference of 10
points in the EORTC QLQ-C30 and its subscales is
con-sidered a clinically relevant difference for patients with
cancer The power of the study to detect an effect of 10
points or more is calculated as follows
The primary outcome is the global quality of life
sub-scale of the EORTC QLQ-C30 (sd = 22.7) at the end of
the study [43] However, we aim for sufficient power for
the most important secondary outcomes– the subscales:
role function, emotional function, cognitive function and
social function of the EORTC QLQ-C30 (clinically
rele-vant difference 10 and sd = 18.7– 22.8) [43] Therefore,
we are aiming for 84 patients per group The power of
the primary outcome then becomes more than 96 %,
and for the relevant subscales at least 80 %, when
ana-lyzing these outcomes with adjustment for baseline (i.e.,
an ANCOVA which has as much power as the t-test or
more depending on the correlation of the baseline
meas-urement with the measmeas-urement at the end of the trial)
Taking a drop-out of at most 15 % into account, a total
number of 193 patients needs to be included to have
suffi-cient power for the primary and secondary outcomes
Statistical analysis
The primary analysis is the comparison of the primary
outcome global quality of life subscale of the EORTC
QLQ-C30 as measured at the end of the research period
analyzed by ANCOVA, i.e., an adjustment for baseline will
be included The secondary analysis of the primary
out-come is a repeated measurements analysis of the sequence
of the repeated measurements in order to compare the
trends between the two groups (mixed model for repeated
measurements) Similar analysis will be carried out on the
secondary outcomes Subgroup analysis will be performed
on demographic and treatment characteristics
Missing data will be analyzed with the last
observa-tion carried forward method for the ANCOVA and a
sensitivity analysis assuming missing data to be
missing-at-random will be performed using a mixed model for
repeated measurements Patients who have died, had
recurrence or metastasis of the breast cancer, or were
diagnosed with another malignancy during the study will
be considered to have dropped out of the study from that
event onwards
Discussion
This study will evaluate the effect of an oncology
nurse-led DT intervention compared to usual care on
improving the quality of life of patients who are treated for breast cancer with curative intent The results will contribute to the actual knowledge and the current dis-cussion about using the DT in daily oncology practice [25-27], as most previous studies were performed for validation of the DT Even though Hollingworth et al performed an RCT to measure the efficacy of the DT, they used the DT once [24] In our study, we will offer
a nurse-led DT intervention repeatedly in a period of more than two years, which makes our study unique and complementary to the existing literature Despite a natural recovery of quality of life over time, we will expect additional improvement when using the DT systematically during a longer period As a primary endpoint, we will use the EORTC QLQ-C30 global quality of life scale In order to compensate for prob-able response shift, we will also inspect the secondary outcomes to measure distress reduction Additionally, the results of this study will give us insight into the tra-jectories of distress and quality of life from diagnosis to 2-year follow up in the usual care group The short-and long-term problems of patients with breast cancer will become apparent Therefore, the outcome of our study may have impact on the future implementation of the DT both nationally and internationally The strengths
of our study are: (1) we will follow the guideline about dis-tress management, (2) we will systematically assess and discuss the DT for approximately 2 years follow up, (3) we will discuss the DT results of all patients in the intervention group with high distress in a psycho-social MDT
Conclusion
In conclusion, the aim of our study is to determine the effectiveness of the systematic use of the DT and the subsequent discussion of the results with a trained on-cology nurse compared with usual care on the quality of life of the patient with breast cancer It is anticipated that the results of the study will have impact on the fu-ture implementation and standardization of the use of the DT as part of routine care It is expected that the data collection will be completed early 2016
Acknowledgments
No acknowledgments to make.
Funding The study is funded by Pink Ribbon, the Netherlands www.pinkribbon.nl Availability of data and materials
Currently not applicable.
Authors ’ contribution All authors contributed to the design of the study FPvA is PhD student and oncology nurse and is responsible for patient recruitment, data collection and writing the manuscript JP and PO developed the idea for this study, supervise the trial, and will contribute to the final analysis of the data and writing of the manuscript MP will support FPvA in patient recruitment, data
Trang 8collection and drafting the manuscript WvdG will be responsible for the
interpretation of the data and writing of the manuscript All authors have
read and approved this final manuscript.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
All patients must give written informed consent to participate in the trial The
study has been approved by the Medical Review Ethics Committee Region
Arnhem-Nijmegen, the Netherlands (2009/293) This study is registered at
ClinicalTrials.gov number NCT01091584.
Author details
1
Department of Medical Oncology, Radboud University Medical Center, P.O.
Box 91016500 Nijmegen, The Netherlands 2 Department of Medical
Psychology, Radboud University Medical Center, Nijmegen, The Netherlands.
3 Institute of Cancer Research and Royal Marsden NHS Foundation Trust,
London, UK.
Received: 8 September 2015 Accepted: 14 July 2016
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